Retrieval wire centering device

ABSTRACT

An occlusive implant system may include a catheter having a lumen extending therethrough, a core wire slidably and rotatably disposed within the lumen, the core wire having a threaded member disposed at a distal end, and a medical implant having an expandable frame, an occlusive element disposed on the frame, and a threaded insert coupled to a proximal portion of the frame, wherein the threaded member is removably coupled to the threaded insert.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/597,232, filed Oct. 9, 2019, which is a continuation of U.S.application Ser. No. 15/647,523, filed Jul. 12, 2017, which is acontinuation of U.S. application Ser. No. 14/586,707 filed Dec. 30,2014, now U.S. Pat. No. 9,730,701, which claims priority benefit to U.S.Provisional Application Ser. No. 61/928,260 filed Jan. 16, 2014.

TECHNICAL FIELD

The disclosure relates generally to percutaneous medical devices andmore particularly to percutaneous medical devices for implantation intothe left atrial appendage (LAA) of a heart.

BACKGROUND

Atrial fibrillation (AF) is the most common sustained cardiacarrhythmia, affecting over 5.5 million people worldwide. Atrialfibrillation is the irregular, chaotic beating of the upper chambers ofthe heart. Electrical impulses discharge so rapidly that the atrialmuscle quivers, or fibrillates. Episodes of atrial fibrillation may lasta few minutes or several days. The most serious consequence of atrialfibrillation is ischemic stroke. It has been estimated that up to 20% ofall strokes are related to atrial fibrillation. Most atrial fibrillationpatients, regardless of the severity of their symptoms or frequency ofepisodes, require treatment to reduce the risk of stroke. The leftatrial appendage (LAA) is a small organ attached to the left atrium ofthe heart as a pouch-like extension. In patients suffering from atrialfibrillation, the left atrial appendage may not properly contract withthe left atrium, causing stagnant blood to pool within its interior,which can lead to the undesirable formation of thrombi within the leftatrial appendage. Thrombi forming in the left atrial appendage may breakloose from this area and enter the blood stream. Thrombi that migratethrough the blood vessels may eventually plug a smaller vesseldownstream and thereby contribute to stroke or heart attack. Clinicalstudies have shown that the majority of blood clots in patients withatrial fibrillation are found in the left atrial appendage. As atreatment, medical devices have been developed which are positioned inthe left atrial appendage and deployed to close off the ostium of theleft atrial appendage. Over time, the exposed surface(s) spanning theostium of the left atrial appendage becomes covered with tissue (aprocess called endothelization), effectively removing the left atrialappendage from the circulatory system and reducing or eliminating theamount of thrombi which may enter the blood stream from the left atrialappendage.

A continuing need exists for improved medical devices and methods tocontrol thrombus formation within the left atrial appendage of patientssuffering from atrial fibrillation.

SUMMARY

A medical implant may include a frame configured to actuate between acollapsed configuration and an expanded configuration, and an occlusiveelement covering at least a portion of the frame, wherein a proximal endof the frame forms a generally tubular portion, the tubular portionbeing configured to attach to a distal end of a core wire, and whereinthe tubular portion of the frame includes a threaded insert coupledthereto.

An occlusive implant system may include a catheter having a lumenextending therethrough, a core wire slidably and rotatably disposedwithin the lumen, the core wire having a threaded member disposed at adistal end thereof, and a medical implant having an expandable frame, anocclusive element disposed on the frame, and a threaded insert coupledto a proximal portion of the frame, wherein the threaded member isremovably coupled to the threaded insert.

A method of making a centering core wire may include obtaining anelongate core wire having a threaded member disposed at a distal endthereof; obtaining a guide element having an aperture or lumen disposedtherein; inserting a proximal end of the elongate core wire into theaperture or lumen; sliding the guide element distally over the elongatecore wire into contact with the threaded member; and applying apolymeric jacket over the elongate core wire from the proximal end tothe guide element; wherein the polymeric jacket retains the guideelement against the threaded member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an example medical implant and deliveryassembly;

FIG. 2 is a partial cross-sectional view of an example medical implantdisposed within a delivery assembly;

FIG. 3 is a perspective view of an example medical implant;

FIG. 3A is a partial cross-sectional view of the example medical implantof FIG. 3;

FIG. 4 is a perspective view of an example medical implant;

FIG. 4A is a partial cross-sectional view of the example medical implantof FIG. 4;

FIGS. 5A and 5B illustrate the extent of relative movement betweencertain elements of the delivery assembly of FIG. 1;

FIG. 6 is a partial cross-sectional view of an example medical implantbeing retracted into a delivery catheter;

FIG. 7 is a side view of an example guide element;

FIG. 8 is a side view of an example guide element;

FIG. 9 is a side view of an example guide element;

FIG. 10 is a side view of an example medical implant connected to anexample core wire having the example guide element of FIG. 7;

FIG. 10A is a side view of the example medical implant of FIG. 10misaligned with an example delivery catheter lumen; and

FIG. 11 is a side view of the example medical implant of FIG. 10 beingcentered with an example delivery catheter lumen.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in greater detail below. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

The terms “upstream” and “downstream” refer to a position or locationrelative to the direction of blood flow through a particular element orlocation, such as a vessel (i.e., the aorta), a heart valve (i.e., theaortic valve), and the like.

The terms “proximal” and “distal” shall generally refer to the relativeposition, orientation, or direction of an element or action, from theperspective of a clinician using the medical device, relative to oneanother. While the terms are not meant to be limiting, “proximal” maygenerally be considered closer to the clinician or an exterior of apatient, and “distal” may generally be considered to be farther awayfrom the clinician, along the length of the medical device.

The terms “monolithic” and “unitary” shall generally refer to an elementor elements made from or consisting of a single structure or baseunit/element. A monolithic and/or unitary element shall excludestructure and/or features made by assembling or otherwise joiningmultiple discrete elements together.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(i.e., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (i.e., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

Weight percent, percent by weight, wt %, wt-%, % by weight, and the likeare synonyms that refer to the concentration of a substance as theweight of that substance divided by the weight of the composition andmultiplied by 100.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g. 1 to 5 includes 1, 1.5,2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

The following description should be read with reference to the drawingswherein like reference numerals indicate like elements throughout theseveral views. The detailed description and drawings are intended toillustrate but not limit the claimed invention. Those skilled in the artwill recognize that the various elements described and/or shown may bearranged in various combinations and configurations without departingfrom the scope of the disclosure. The various individual elementsdescribed below, even if not explicitly shown in a particularcombination, are nevertheless contemplated as being combinable orarrangeable with each other to form other additional embodiments or tocomplement and/or enrich the described embodiment(s), as would beunderstood by one of ordinary skill in the art.

The occurrence of thrombi in the left atrial appendage (LAA) duringatrial fibrillation may be due to stagnancy of the blood pool in theLAA. The blood may still be pulled out of the left atrium by the leftventricle, however less effectively due to the irregular contraction ofthe left atrium caused by atrial fibrillation. Therefore, instead of anactive support of the blood flow by a contracting left atrium and leftatrial appendage, filling of the left ventricle may depend primarily orsolely on the suction effect created by the left ventricle. Further, thecontraction of the left atrial appendage may not be in sync with thecycle of the left ventricle. For example, contraction of the left atrialappendage may be out of phase up to 180 degrees with the left ventricle,which may create significant resistance to the desired flow of blood.Further still, most left atrial appendage geometries are complex andhighly variable, with large irregular surface areas and a narrow ostiumor opening compared to the depth of the left atrial appendage. Theseaspects as well as others, taken individually or in variouscombinations, may lead to high flow resistance of blood out of the leftatrial appendage.

In an effort to reduce the occurrence of thrombi formation within theleft atrial appendage and prevent thrombi from entering the blood streamfrom within the left atrial appendage, medical devices have beendeveloped that close off the left atrial appendage from the heart and/orcirculatory system, thereby lowering the risk of stroke due tothrombolytic material entering the blood stream from the left atrialappendage. Difficulties encountered during placement of said medicaldevice(s) may occasionally require removal and/or recapture procedures.In an effort to ease recapture procedures and/or to provide a medicaldevice suitable for long term implantation, favorable new features havebeen developed.

Turning now to the figures, FIG. 1 illustrates an example deliveryassembly and/or implant system 10 including an example medical implant20 disposed at a distal end 32 of an example core wire 30. The core wire30 may be slidably and/or rotatably disposed within a lumen 42 of adelivery catheter 40. In some embodiments, a proximal end 34 of the corewire 30 may extend proximally of a proximal end of the delivery catheter40 for manual manipulation by a clinician or practitioner. In someembodiments, the example medical implant 20 may be removably attached,joined, or otherwise connected to the distal end 32 of the example corewire 30. An example medical implant 20 may be configured to actuate froma collapsed configuration to an expanded configuration when (or afterbeing) extended distally from the delivery catheter 40, as seen in FIG.1 for example. FIG. 2 illustrates the example medical implant 20disposed within a distal portion of the lumen 42 of the deliverycatheter 40 in the collapsed configuration. It is contemplated that anyand/or all example medical implants disclosed herein may be used inaccordance with and/or be associated with the example delivery assemblyand/or implant system 10 described above.

FIGS. 3 and 3A illustrate an example medical implant 100 having a frame110 configured to actuate between a collapsed configuration and anexpanded configuration. In some embodiments, the example medical implant100 may include an occlusive element 120 disposed on, disposed over,disposed about, or covering at least a portion of the frame 110. In someembodiments, the occlusive element 120 may be disposed on, disposedover, disposed about or cover at least a portion of an outer (oroutwardly-facing) surface of the frame 110. In some embodiments, aproximal end of the frame 110 may form a generally tubular portion 112,the generally tubular portion 112 being configured to attach to orcouple to a distal end of a core wire 30. In some embodiments, thegenerally tubular portion 112 of the frame 110 may include a threadedinsert 130 coupled thereto. In some embodiments, the threaded insert 130may be at least partially disposed within the generally tubular portion112 of the frame 110. In some embodiments, the threaded insert 130 maybe configured to and/or adapted to couple with, join to, mate with, orotherwise engage a threaded member 36 disposed at the distal end 32 ofthe core wire 30.

In some embodiments, a first portion of the occlusive element 120 may bedisposed between the threaded insert 130 and the generally tubularportion 112. In some embodiments, the first portion of the occlusiveelement 120 may be pinched or held between the threaded insert 130 andthe generally tubular portion 112. In some embodiments, the threadedinsert 130 may include a curved or angled proximally-facing surface 132that extends radially outward from threads formed within a center of thethreaded insert 130. In some embodiments, the curved or angledproximally-facing surface 132 may extend proximally of the occlusiveelement 120 in the expanded configuration and/or the collapsedconfiguration. In some embodiments, the curved or angledproximally-facing surface 132 may have an outer extent that is disposedradially outward from the first portion of the occlusive element 120and/or the generally tubular portion 112. In some embodiments, the frame110 may include a plurality of proximally-facing hooks 118 disposedabout a periphery of the frame 110 in the expanded configuration. Insome embodiments, the plurality of proximally-facing hooks 118 mayprovide an anchoring mechanism to aid in retaining a deployed medicalimplant 100 at a target site within a patient's anatomy (i.e., the leftatrial appendage, for example).

FIGS. 4 and 4A illustrate an example medical implant 200 having a frame210 configured to actuate between a collapsed configuration and anexpanded configuration. In some embodiments, the example medical implant200 may include an occlusive element 220 disposed on, disposed over,disposed about, or covering at least a portion of the frame 210. In someembodiments, the occlusive element 220 may be disposed on, disposedover, disposed about or cover at least a portion of an outer (oroutwardly-facing) surface of the frame 210. In some embodiments, aproximal end of the frame 210 may form a generally tubular portion 212,the generally tubular portion 212 being configured to attach to orcouple to a distal end 32 of a core wire 30. In some embodiments, thegenerally tubular portion 212 of the frame 210 may include a threadedinsert 230 coupled thereto. In some embodiments, the frame 210 mayinclude an annular collar member 240 at least partially disposed withinthe generally tubular portion 212 and coupled thereto. In someembodiments, the threaded insert 230 may be coupled to the annularcollar member 240. In some embodiments, the threaded insert 230 may beat least partially disposed within the annular collar member 240. Insome embodiments, a pin element 250 may couple the annular collar member240 and/or the threaded insert 230 to the frame 210 and/or to eachother. In some embodiments, the annular collar member 240 and/orthreaded insert 230 may be fixedly attached to and/or coupled with thegenerally tubular portion 212 of the frame 210 and/or each other. Insome embodiments, the annular collar member 240 and/or threaded insert230 may be permanently attached to and/or coupled with the generallytubular portion 212 of the frame 210 and/or each other. In someembodiments, the annular collar member 240 and/or threaded insert 230may be removably attached to and/or coupled with the generally tubularportion 212 of the frame 210 and/or each other. In some embodiments, thethreaded insert 230 may be configured to and/or adapted to reversiblyand/or removably couple with, join to, mate with, or otherwise engage athreaded member 36 disposed at the distal end 32 of the core wire 30.

In some embodiments, a first portion of the occlusive element 220 may bedisposed between the threaded insert 230 and the annular collar member240. In some embodiments, the first portion of the occlusive element 220may be pinched or held between the threaded insert 230 and the annularcollar member 240. In some embodiments, the threaded insert 230 may bedisposed distally of a portion of the occlusive element 220 disposedoutside of the annular collar member 240 in the expanded configurationand/or the collapsed configuration. In some embodiments, an outerportion of the occlusive element 220 may be defined as that part of theocclusive element 220 disposed outside of the annular collar member 240.In some embodiments, the outer portion of the occlusive element 220 maybe disposed radially outward from the threaded insert 230 in theexpanded configuration. In some embodiments, the frame 210 may include aplurality of proximally-facing hooks 218 disposed about a periphery ofthe frame 210 in the expanded configuration. In some embodiments, theplurality of proximally-facing hooks 218 may provide an anchoringmechanism to aid in retaining a deployed medical implant 200 at a targetsite within a patient's anatomy (i.e., the left atrial appendage, forexample).

In some embodiments, the medical implant 200 of FIG. 4 may have areduced amount of exposed material (i.e., metallic material) at thethreaded insert compared to the medical implant 100 of FIG. 3.Applicants have found that reducing the amount of metallic materialexposed to the bloodstream may provide certain advantages such asreduced thrombus formation and/or more rapid endothelization.

As illustrated in FIGS. 5A and 5B, in some embodiments, a core wire 30may have a maximum outer diameter that is considerably smaller than aminimum inner diameter of a lumen 42 of a delivery catheter 40. Theinner diameter of the lumen 42 of the delivery catheter 40 may be sizedto accommodate a medical implant 20 within the lumen 42 in a collapsedconfiguration. The outer diameter of the core wire 30 may be sized toprovide sufficient flexibility to the core wire 30 and the deliveryassembly and/or implant system 10 for navigation through a patient'svasculature to a target site (i.e., the left atrial appendage, forexample) while maintaining a desired level of torquability and/orpushability.

As may be seen in FIGS. 5A and 5B, the difference in size between thecore wire 30 and the lumen 42 may allow a significant amount of “play”,or lateral movement relative to a central axis of the lumen 42, betweenthe core wire 30 and the delivery catheter 40. As such, a medicalimplant 20 and/or the distal end 32 of the core wire 30 may becomemisaligned with the lumen 42 of the delivery catheter 40 after beingextended distally from the lumen 42, such as during deployment of themedical implant 20 and/or during removal or recapture of the medicalimplant 20. During some procedures, it may be necessary to withdrawand/or recapture the medical implant 20 after initial placement, priorto releasing the medical implant 20 from the core wire 30. For example,if an inadequate seal is achieved between the medical implant 20 and thesurrounding tissue (i.e., the ostium of the left atrial appendage, forexample), a practitioner may recapture the medical implant 20 and deployit again to ensure proper placement. Alternatively, it may be necessaryat some point to remove the medical implant after deployment and releasewithin a patient's anatomy. During recapture procedures, a distal end 44of the delivery catheter 40 may come into contact with the medicalimplant 20 and/or the occlusive element disposed thereon, as seen inFIG. 6. If the medical implant 20 is not generally centered within thedistal opening of the lumen 42, the forces required to actuate the framefrom the expanded configuration to the collapsed configuration may beincreased, and in some cases high enough to result in tearing of, ordamage to, the occlusive element as the occlusive element is pinchedbetween the frame and the delivery catheter 40, thereby requiring fullremoval from patient and replacement of the implant 20 before theprocedure may proceed. Accordingly, a feature which may result incentering of the implant 20 within the lumen 42 may be beneficial in atleast some circumstances.

FIGS. 7-9 illustrate an example core wire 30 having a threaded member 36at a distal end 32. In some embodiments, the threaded member 36 may beconfigured and/or adapted to engage, attach to, connect to, and/or matewith a threaded insert of an example medical implant 20. The examplecore wire 30 may include a guide element 35 disposed about the core wire30 adjacent a proximal end of the threaded member 36. The guide element35 may be shaped and/or configured to center the core wire 30 and/or themedical implant 20 within the lumen 42 of the delivery catheter 40. Insome embodiments, the guide element 35 may include a curved, convexproximal surface and a generally flat distal surface, as shown in FIG.7, for example. In some embodiments, the guide element 35 may include aconical proximal surface and a generally flat distal surface, as shownin FIG. 8, for example. In some embodiments, the guide element 35 mayinclude a generally rounded, bulbous, convex outer surface, as shown inFIG. 9, for example. In some embodiments, a distal surface of the guideelement 35 may be configured to and/or adapted to contact or engage themedical implant 20 when the threaded member 36 is engaged with, attachedto, connected to, and/or mated with the threaded insert, as seen forexample in FIGS. 10-11. In some embodiments, a distal surface of theguide element 35 may not contact or engage the medical implant 20 whenthe threaded member 36 is engaged with, attached to, connected to,and/or mated with the threaded insert, and the distal surface of theguide element 35 may be spaced apart from the medical implant 20.

In some embodiments, an occlusive implant system 10 may include adelivery catheter 40 having a lumen 42 extending therethrough, a corewire 30 slidably and/or rotatably disposed within the lumen 42, the corewire 30 having a threaded member 36 disposed at a distal end 32 thereof,and a medical implant 20 having an expandable frame, an occlusiveelement disposed on the frame, and a threaded insert coupled to aproximal portion of the frame, wherein the threaded member 36 may beremovably coupled to the threaded insert, as shown for example in FIGS.10-11. In the exemplary figures provided herewith, the example core wire30 is shown attached to the example medical implant 200 describedherein. However, the example core wire 30 may also be used with theexample medical implant 100 described herein or other similar medicalimplants/devices. In some embodiments, the frame may be actuatablebetween a collapsed configuration and an expanded configuration. In someembodiments, the frame may be self-expanding. In some embodiments, theframe may be manually actuatable from the collapsed configuration to theexpanded configuration. In some embodiments, a portion of the occlusiveelement may be disposed between the threaded insert and the proximalportion of the frame. In some embodiments, a portion of the occlusiveelement may extend proximally of the threaded insert. In someembodiments, the medical implant 20 may include an annular collar memberdisposed between the proximal portion of the frame and the threadedinsert. In some embodiments, the annular collar member and/or thethreaded insert may be removably and/or reversibly coupled to, attachedto, connected to, and/or engaged with the proximal portion of the frameby a pin element. In some embodiments, the annular collar member and/orthe threaded insert may be fixedly and/or permanently coupled to,attached to, connected to, and/or engaged with the proximal portion ofthe frame, such as by adhesion, welding, mechanical fastening, and thelike.

In some embodiments the core wire 30 may include a guide element 35disposed adjacent a proximal end of the threaded member 36. In someembodiments, the guide element 35 may be configured and/or adapted tocenter the core wire 30 within the lumen 42 of the delivery catheter 40.In some embodiments, the guide element 35 may be slidably disposed aboutthe core wire 30. In some embodiments, the guide element 35 may bepositioned against the threaded member 36 and axially retained in placeby a polymeric jacket 38 disposed over and/or on the core wire 30 and incontact with the guide element 35 at a distal end of the polymericjacket 38. In some embodiments, the guide element 35 may be fixedlyand/or permanently attached to the core wire 30, such as by adhesion,welding, mechanical fastening, and the like. In some embodiments, theguide element 35 may be integrally formed with the core wire 30 as amonolithic unit. In some embodiments, a marker band 37 may be disposedabout the core wire 30 adjacent the guide element 35. In someembodiments, the marker band 37 may be disposed over the polymericjacket 38 and may crimp a distal portion of the polymeric jacket 38covering the core wire 30 onto the core wire 30. In some embodiments, adiscrete piece of polymeric material 39 may be disposed over the markerband 37, as seen for example in FIGS. 7-9. In some embodiments, thediscrete piece of material 39 may be heated and/or joined to thepolymeric jacket 38, such as by reflow, for example, to form a singlepolymeric cover member. In some embodiments, the marker band 37 may beat least partially encapsulated by the polymeric jacket 38, the discretepiece of polymeric material 39, and/or the polymeric cover member. Insome embodiments, the discrete piece of polymeric material 39 may formthe guide element 35, as seen for example in FIG. 9.

In some embodiments, a core wire 30 may include a stepped outer diameterand/or a narrowed distal section adjacent a threaded member 36 disposedat the distal end 32, as may be seen in FIGS. 10-11. A polymeric jacket38 disposed over and/or on the core wire 30 may be formed, crimped, orotherwise forced into place over the narrowed distal section, resultingin a portion of the polymeric jacket 38 being mechanically locked intoplace and preventing the polymeric jacket 38 from sliding proximallyrelative to the core wire 30. In some embodiments, the marker band 37may mechanically lock the polymeric jacket 38 in place relative to thecore wire 30. The mechanical locking may occur with or without the guideelement 35 disposed adjacent the threaded member 36.

A method of making a centering core wire may include some or all of thesteps of:

obtaining or providing an elongate core wire 30 having a threaded member36 disposed at a distal end 32 thereof;

obtaining or providing a guide element 35 having an aperture or lumendisposed therein;

inserting a proximal end 34 of the elongate core wire 30 into theaperture of lumen, such that a proximally-facing surface of the guideelement 35 provides a generally tapered, angled, or convex surface in aradially outward and distal direction from the core wire 30;

sliding the guide element 35 distally over the elongate core wire 30 andinto contact with a proximal end of the threaded member 36;

applying a polymeric jacket 38 over the elongate core wire 30 from theproximal end 34 of the elongate core wire 30 to the guide element 35,wherein the polymeric jacket 38 axially holds and/or retains the guideelement 35 against the threaded member 36;

disposing a marker band 37 over the polymeric jacket 38 adjacent theguide element 35;

crimping the marker band 37 onto the elongate core wire 30 such that thepolymeric jacket 38 is fixed in position along the elongate core wire30;

disposing a piece of polymeric material 39 about the marker band 37; and

heating the polymeric jacket 38 and the piece of polymeric material 39such that the polymeric jacket 38 and the piece of polymeric material 39are joined together by reflow to form a polymeric cover member.

In some embodiments of the method, the marker band 37 may be at leastpartially encapsulated by reflow of the polymeric jacket 38 and thepiece of polymeric material 39. In other words, the marker band 37 maybe at least partially encapsulated by the polymeric cover member formedby reflow of the polymeric jacket 38 and the piece of polymeric material39. In some embodiments of the method, the elongate core wire 30 mayinclude a stepped outer diameter and/or a narrowed section adjacent thethreaded member 36 for providing a mechanical interlock between the corewire 30 and the polymeric jacket 38.

FIGS. 3 and 4 illustrate an example medical implant having a membrane orocclusive element disposed over at least a portion of the frame. In someembodiments, at least some of the plurality of proximally-facing hooksproject through the membrane or occlusive element. In some embodiments,the membrane or occlusive element may be attached to the frame at eachproximally-facing hook, for example, by passing each proximally-facinghook through the membrane or occlusive element, such as through a poreor aperture. In some embodiments, the membrane or occlusive element maybe attached to the frame by other suitable attachment means, such as butnot limited to, adhesive(s), sutures or thread(s), welding or soldering,or combinations thereof. In some embodiments, the membrane or occlusiveelement may be permeable or impermeable to blood and/or other fluids,such as water. In some embodiments, the membrane or occlusive elementmay include a polymeric membrane, a metallic or polymeric mesh, a porousfilter-like material, or other suitable construction. In someembodiments, the membrane or occlusive element prevents thrombi (i.e.blood clots, etc.) from passing through the membrane or occlusiveelement and out of the left atrial appendage into the blood stream. Insome embodiments, the membrane or occlusive element promotesendothelization after implantation, thereby effectively removing theleft atrial appendage from the patient's circulatory system.

The frame may be compliant and substantially conform to and/or be insealing engagement with the shape and/or geometry of a lateral wall of aleft atrial appendage in the expanded configuration. In someembodiments, the medical implant may expand to a size, extent, or shapeless than or different from a maximum unconstrained extent, asdetermined by the surrounding tissue and/or lateral wall of the leftatrial appendage. Reducing the thickness of the plurality of struts mayincrease the flexibility and compliance of the support frame and/or theimplant, thereby permitting the implant to conform to the tissue aroundit, rather than forcing the tissue to conform to the implant.

In some embodiments, the plurality of struts of the frame, the pluralityof proximally-facing hooks, and/or the core wire may be formed of orinclude a metallic material, a metallic alloy, a ceramic material, arigid or high performance polymer, a metallic-polymer composite,combinations thereof, and the like. Some examples of some suitablematerials may include metallic materials and/or alloys such as stainlesssteel (e.g., 303, 304v, or 316L stainless steel), nickel-titanium alloy(e.g., nitinol, such as super elastic or linear elastic nitinol),nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, nickel,titanium, platinum, or alternatively, a polymer material, such as a highperformance polymer, or other suitable materials, and the like. The wordnitinol was coined by a group of researchers at the United States NavalOrdinance Laboratory (NOL) who were the first to observe the shapememory behavior of this material. The word nitinol is an acronymincluding the chemical symbol for nickel (Ni), the chemical symbol fortitanium (Ti), and an acronym identifying the Naval Ordinance Laboratory(NOL).

In some embodiments, the plurality of struts of the frame, the pluralityof proximally-facing hooks, and/or the marker band may be mixed with,may be doped with, may be coated with, or may otherwise include aradiopaque material. Radiopaque materials are understood to be materialscapable of producing a relatively bright image on a fluoroscopy screenor another imaging technique such as X-ray during a medical procedure.This relatively bright image aids the user of device in determining itslocation. Suitable radiopaque materials may include, but are not limitedto, bismuth subcarbonate, iodine, gold, platinum, palladium, tantalum,tungsten or tungsten alloy, and the like.

In some embodiments, the membrane or occlusive element may be formed ofor include a polymeric material, a metallic or metallic alloy material,a metallic-polymer composite, combinations thereof, and the like. Insome embodiments, the membrane or occlusive element is preferably formedof polyethylene terephthalate (PET) such as DACRON®, or expandedpolytetrafluoroethylene (ePTFE). Other examples of suitable polymers mayinclude polyurethane, a polyether-ester such as ARNITEL® available fromDSM Engineering Plastics, a polyester such as HYTREL® available fromDuPont, a linear low density polyethylene such as REXELL®, a polyamidesuch as DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem, an elastomeric polyamide, a block polyamide/ether, a polyetherblock amide such as PEBA available under the trade name PEBAX®,silicones, polyethylene, Marlex high-density polyethylene,polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polyimide(PI), and polyetherimide (PEI), a liquid crystal polymer (LCP) alone orblended with other materials.

In some embodiments, the delivery catheter and/or the medical implantmay be made from, may be mixed with, may be coated with, or mayotherwise include a material that provides a smooth, slippery outersurface. In some embodiments, the delivery catheter and/or the medicalimplant may include or be coated with a lubricious coating, ahydrophilic coating, a hydrophobic coating, a drug-eluting material, ananti-thrombus coating, or other suitable coating depending on theintended use or application.

It should be understood that although the above discussion was focusedon a medical device and methods of use within the vascular system of apatient, other embodiments of medical devices or methods in accordancewith the disclosure can be adapted and configured for use in other partsof the anatomy of a patient. For example, devices and methods inaccordance with the disclosure can be adapted for use in the digestiveor gastrointestinal tract, such as in the mouth, throat, small and largeintestine, colon, rectum, and the like. For another example, devices andmethods can be adapted and configured for use within the respiratorytract, such as in the mouth, nose, throat, bronchial passages, nasalpassages, lungs, and the like. Similarly, the apparatus and/or medicaldevices described herein with respect to percutaneous deployment may beused in other types of surgical procedures as appropriate. For example,in some embodiments, the medical devices may be deployed in anon-percutaneous procedure, such as an open heart procedure. Devices andmethods in accordance with the invention can also be adapted andconfigured for other uses within the anatomy.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

What is claimed is:
 1. A medical implant, comprising: a frame configuredto actuate between a collapsed configuration and an expandedconfiguration, wherein the expanded configuration of the frame iscompliant and is configured to substantially conform to a shape and/orgeometry of a lateral wall of a left atrial appendage; and to be insealing engagement therewith when implanted in the left atrialappendage; an occlusive element configured to cover at least a proximalportion of the frame, which proximal portion spans an opening formed bythe lateral wall of the left atrial appendage in the expandedconfiguration of the frame, and is configured to cover at least aportion of the lateral wall of the left atrial appendage distal of theopening; wherein a proximal end of the frame includes a generallytubular portion, the generally tubular portion being configured toattach to a distal end of a core wire; wherein the generally tubularportion of the frame includes a threaded insert coupled thereto, whereina proximalmost extent of the threaded insert is substantially coplanarwith a plane defined by three or more proximalmost extents of the framein the expanded configuration, wherein the portion of the occlusiveelement covering the opening is substantially coplanar with theproximalmost extent of the threaded insert and the plane defined by theproximalmost extent of the frame in the expanded configuration.
 2. Themedical implant of claim 1, wherein the frame includes an annular collarmember at least partially disposed within the generally tubular portionand coupled thereto, the threaded insert being coupled to the annularcollar member.
 3. The medical implant of claim 2, wherein the threadedinsert is disposed within the annular collar member.
 4. The medicalimplant of claim 2, wherein a portion of the occlusive element isdisposed between the threaded insert and the annular collar member. 5.The medical implant of claim 3, further including a pin element couplingthe annular collar member to the frame.
 6. The medical implant of claim5, wherein the threaded insert is disposed distally of a portion of theocclusive element disposed outside of the annular collar member.
 7. Themedical implant of claim 1, wherein the frame includes a plurality ofproximally-facing hooks disposed about a periphery of the frame in theexpanded configuration.
 8. The medical implant of claim 4, wherein anouter portion of the occlusive element is defined as that part of theocclusive element disposed outside of the annular collar member, whereinthe outer portion of the occlusive element is disposed radially outwardfrom the threaded insert in the expanded configuration.
 9. The medicalimplant of claim 1, wherein the distal end of the core wire includes athreaded member configured to mate with the threaded insert.